SavvyHealth App for Multiple Sclerosis

(SavvyHealth Trial)

Overseen By Chungyi Chiu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the effectiveness after using a new individualized-health e-library app named SavvyHealth among people with multiple sclerosis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SavvyHealth App for Multiple Sclerosis treatment?

Research shows that mobile health apps can help people with multiple sclerosis improve their dexterity and manage symptoms like fatigue and mental health. Apps like levidex and IDoThis have been used to support health behavior changes and self-management, which can enhance quality of life for those with MS. ^{1 2 3 4 5}

Is the SavvyHealth App safe for use in humans?

There is no specific safety data available for the SavvyHealth App or its other names in the provided research articles. ^{2 6 7 8 9}

How is the SavvyHealth App treatment for multiple sclerosis different from other treatments?

The SavvyHealth App is unique because it is a digital health application designed to promote self-management and health behavior changes in people with multiple sclerosis, offering personalized information and support through a mobile platform, unlike traditional treatments that may not focus on self-management or be as accessible. ^{1 2 10 11 12}

Research Team

Chungyi Chiu

Principal Investigator

University of Illinois at Urbana-Champaign

Eligibility Criteria

This trial is for adults over 18 with multiple sclerosis (MS) who are willing to use a new health e-library app, SavvyHealth, and take surveys. Participants must have at least one other health condition alongside MS and be open to being randomly placed in either the intervention or control group.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

I am open to being placed in any group of the study.

I am willing to complete a survey.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the SavvyHealth app for 21 days

3 weeks

2 visits (virtual)

Follow-up

Participants are monitored for changes in self-management skills after app usage

1 week

Treatment Details

Interventions

• SavvyHealth

Trial Overview The study is testing the effectiveness of SavvyHealth, an individualized-health e-library app designed for people with MS. The goal is to see if using the app for three weeks can help manage their condition better than not using it.

Participant Groups

Group I: SavvyHealth Experimental Treatment 1 Intervention

Participants will use the new app, SavvyHealth, for 21 days.

Group II: Waiting list Active Control 1 Intervention

Participants will be on the waiting list.

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Findings from Research

A randomized controlled trial involving 48 individuals with multiple sclerosis found that a tablet app-based training program did not significantly improve overall arm and hand function compared to a control strengthening exercise program.

However, the app-based training showed effectiveness in enhancing specific skills like fine coordinated finger movements and grip strength, suggesting it can be a useful home-based option for individuals with MS looking to improve dexterity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet app-based dexterity training in multiple sclerosis (TAD-MS): a randomized controlled trial. van Beek, JJW., Lehnick, D., Pastore-Wapp, M., et al.[2022]

The digital health application 'levidex' was found to be practical and acceptable for people with multiple sclerosis (pwMS) with moderate to severe disability, as evidenced by positive participant feedback and a completion rate of 47.4% for all modules over a six-month period.

While the study showed that levidex could facilitate health behavior changes, no significant improvements were observed in secondary outcomes like empowerment or stress management, indicating the need for further research with larger sample sizes and longer follow-up to assess its true efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study. Kutzinski, M., Krause, N., Riemann-Lorenz, K., et al.[2023]

A wellness program for people with multiple sclerosis (MS) showed significant improvements in various health domains, including functional status, fatigue, and depression, based on data from 65 participants.

The program's focus on education and self-efficacy helped reduce fear-avoidance beliefs and pain, suggesting that a multidimensional approach can enhance overall well-being in MS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. Hart, DL., Memoli, RI., Mason, B., et al.[2021]

The BRISA app, used by 2095 multiple sclerosis patients in Germany, revealed that most users are female and aged between 26 and 55, with relapsing-remitting MS being the most common type.

The study identified fatigue, concentration disorders, tingling, forgetfulness, and pain as the top symptoms affecting users, emphasizing the need for personalized disease management strategies based on real-world data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. Balakrishnan, P., Groenberg, J., Jacyshyn-Owen, E., et al.[2022]

The IDoThis app, developed for self-management of multiple sclerosis (MS), was positively received by 75% of participants, indicating it effectively improved their MS self-management status after three weeks of use.

The app includes valuable features like training modules and condition monitoring, but users expressed a need for additional content on fatigue and sleep management to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile app (IDoThis) for multiple sclerosis self-management: development and initial evaluation. Salimzadeh, Z., Damanabi, S., Ferdousi, R., et al.[2022]

The FlywheelMS study is collecting a large, deidentified health record data set from 5000 adults with multiple sclerosis (MS) across the U.S., utilizing a patient-centric platform to improve understanding of disease patterns and care.

As of November 2020, over 4176 participants have enrolled, with a high data abstraction precision of 97.8%, indicating that this method can reliably generate valuable insights for MS research and potentially for other diseases in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generating real-world data from health records: design of a patient-centric study in multiple sclerosis using a commercial health records platform. Hanson, G., Chitnis, T., Williams, MJ., et al.[2022]

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

In a study of 234 newly diagnosed multiple sclerosis (MS) patients, significant health behavior issues were identified, including high rates of smoking (19%), obesity (15%), and insufficient physical activity (36%), indicating a need for targeted lifestyle interventions.

The research highlighted that higher disability scores (EDSS) were linked to worse health outcomes, such as increased T2-lesion burden and lower quality of life, suggesting that individualized counseling on health behaviors could improve patient outcomes in early MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of health behaviour and clinical manifestation in early multiple sclerosis in Germany - Baseline characteristics of the POWER@MS1 randomised controlled trial. Krause, N., Derad, C., von Glasenapp, B., et al.[2023]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

A study involving 98 participants with multiple sclerosis found that performance expectancy and social influence are significant predictors of acceptance for mobile health apps, indicating that users are more likely to adopt these tools if they believe they will be helpful and if they receive social support.

Despite high smartphone usage (92% of participants), 63% had no experience with MS apps, highlighting a gap in utilization that could be addressed by improving perceptions of the apps' benefits and fostering social encouragement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance of Mobile Health Apps for Disease Management Among People With Multiple Sclerosis: Web-Based Survey Study. Apolinário-Hagen, J., Menzel, M., Hennemann, S., et al.[2020]

The study found that e-health literacy significantly differed between technology users and nonusers among 156 participants with multiple sclerosis, indicating that those who use tablets and recommended websites have better health literacy.

Participants' e-health literacy scores were weakly correlated with age, marital status, and education level, suggesting that these factors may influence how well individuals with MS can access and understand health information online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

e-Health Literacy Status of Individuals with Multiple Sclerosis in Turkey. Tosun, AT., Isiklar, C., Yildirim, M., et al.[2023]

The TEAMS (Tele-Exercise and Multiple Sclerosis) app was developed through a user-centered design process involving 21 participants, including 10 with multiple sclerosis, to create personalized exercise programs that accommodate varying functional limitations.

Usability testing showed significant improvement, with a 53% reduction in problems reported by participants in the second test, indicating that the app is effective and user-friendly for promoting home-based exercise among people with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEAMS (Tele-Exercise and Multiple Sclerosis), a Tailored Telerehabilitation mHealth App: Participant-Centered Development and Usability Study. Thirumalai, M., Rimmer, JH., Johnson, G., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Tablet app-based dexterity training in multiple sclerosis (TAD-MS): a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Acceptability of a digital health application to empower persons with multiple sclerosis with moderate to severe disability: single-arm prospective pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Developing a wellness program for people with multiple sclerosis: description and initial results. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Demographic Patterns of MS Patients Using BRISA: An MS-Specific App in Germany. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A mobile app (IDoThis) for multiple sclerosis self-management: development and initial evaluation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Generating real-world data from health records: design of a patient-centric study in multiple sclerosis using a commercial health records platform. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Association of health behaviour and clinical manifestation in early multiple sclerosis in Germany - Baseline characteristics of the POWER@MS1 randomised controlled trial. [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Acceptance of Mobile Health Apps for Disease Management Among People With Multiple Sclerosis: Web-Based Survey Study. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

e-Health Literacy Status of Individuals with Multiple Sclerosis in Turkey. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

TEAMS (Tele-Exercise and Multiple Sclerosis), a Tailored Telerehabilitation mHealth App: Participant-Centered Development and Usability Study. [2019]